Rapid Test Cartridges for LAL & Beta-D-Glucan Detection Assays

The Charles River Endosafe compendial cartridge technology is innovative response to our customers’ need for higher sensitivity and faster quantitative results in the kinetic chromogenic method.

Designed to optimize and refine use of LAL, FDA-licensed cartridge technology uses 95% less amount of the raw material and accessories than the traditional LAL testing methods while reducing time-consuming preparation and technician variability.

All of our highly flexible rapid kinetic chromogenic LAL testing platforms utilize our FDA-licensed LAL cartridges as well as a variety of non-regulated cartridges for simple, 15-minute testing. The cartridges are pre-loaded with all of the reagents required to perform an LAL test, eliminating preparation of multiple reagents and reducing the opportunity for technician error.

Compendial FDA-Licensed Kinetic Chromogenic LAL Cartridges

Our LAL test cartridges use existing FDA-licensed Endosafe chromogenic LAL reagent to measure color intensity directly related to the endotoxin concentration in a sample.

  • Real-time quantitative endotoxin analysis in 15 minutes
  • Proven USP/EP/JP-compliant BET method
  • Licensed by the FDA in 2006 for in-process and final product release testing
  • Detects between 0.005 and 10 EU/mL

Beta-Glucan Cartridges

The Beta-glucan assay is a rapid, in-process test designed for investigational purposes to ensure that products do not contain (1,3)-β-D glucans. Glucans are known to cause false-positive results in the LAL test, which could trigger an investigation.

  • Designed to mimic kinetic chromogenic method by measuring color intensity
  • Results in approximately 30 minutes
  • Sensitivity range of 10-1,000 pg/mL

Endosafe® - PTS™ Glucan Assay - in LAL assays, it is known that glucan molecules may be present in the cell walls of most yeasts and molds, which then may cause a false-positive result and trigger further investigations. Endosafe®-PTS™ Glucan Assay is the perfect choice to quick and easy glucan quantification, leading to better process monitoring and out-of-specifications (OOS) resolutions. Glucan cartridges can be used on the same PTS™ equipment used for endotoxin testing.

Product

Code

Beta-Glucan cartridges (10/pack) RMMGS1000
  • The four reservoirs represent duplicate sample and spike channels that allow the test to automatically run in duplicate. This design satisfies the harmonized USP/EP BET requirements for LAL testing.
  • Each channel ends in an optical cell where the samples are analyzed by the cartridge instrument. In the sample channels, the reader draws and mixes the sample with the LAL test reagent.
  • In the spike channels, the sample is mixed with the Charles River Endosafe LAL reagent and positive control. Each sample is then combined with the chromogenic substrate and incubated.
  • After mixing, the reader measures color intensity directly related to the endotoxin concentration and compares the reaction times to the archived standard curve.

Charles River Endosafe Compendial LAL Cartridges

Product Sensitivity EU/mL Code
10 single packs of LAL test cartridges
(FDA-licensed)
0.1 PTS201F
0.05 PTS2005F
0.01 PTS2001F
10 single packs of LAL test cartridges
(unlicensed: for R&D use only)
0.1 PTS201
0.05 PTS2005
0.01 PTS2001
Multi-packs of 25 LAL test cartridges
(5/pouch) (FDA-licensed)
0.05 PTS5505F
0.01 PTS5501F
10 single packs of inhibition/enhancement screening cartridges*   PTS220
Do you have a question about this product?

    This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.